Dosing and uses of Elmiron (pentosan polysulfate sodium)
Adult dosage forms and strengths
capsule
- 100mg
Interstitial Cystitis
Indicated for bladder pain associated with interstitial cystitis
100 mg PO q8hr
Administration: 1 hour before or 2 hours after meals with water
Reassess every 3 Months
Sickle Cell Disease (Orphan)
Orphan indication sponsors
- Vanguard Therapeutics, Inc; Eagle Trace Dr; Half Moon Bay, CA 94019
- TRF Pharma, Inc; 863 Mitten Road; Burlingame, CA 94010
Mucopolysaccharidosis (Orphan)
Brand name: Lysosan
Orphan designation for treatment of MPS type VI
Sponsor
- Plexcera Therapeutics, LLC; 4445 North Highway A1A, Suite 241; Vero Beach, FL 32963
Pediatric dosage forms and strengths
<16 years: Safety and efficacy not established
Elmiron (pentosan polysulfate sodium) adverse (side) effects
1-10%
Alopecia (4%)
Diarrhea (4%)
Nausea (4%)
Headache (3%)
Abdominal pain (2%)
Indigestion (2%)
Postmarketing Reports
Rectal hemorrhage
Elevated LFTs
Anemia
Leukopenia
Partial thromboplastin time increased
Prothrombin time increased
Thrombocytopenia
Optic neuritis
Retinal hemorrhage
Warnings
Contraindications
Hypersensitivity
Cautions
Hepatic or splenic disorders
Bleeding diathesis
Risk of alopecia
Pregnancy and lactation
Pregnancy category: B
Lactation: not known if excreted in breast milk, use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Elmiron (pentosan polysulfate sodium)
Mechanism of action
Low molecular weight heparin-like compound; elicits weak anticoagulant (1/15 activity of heparin) and fibrinolytic effects
MOA in cystitis unknown; drug appears to attach to the bladder wall mucosa where it may act as a buffer to protect tissues from irritating substances in the urine
Pharmacokinetics
Absorption: 6%
Half-Life, Elimination: 4.8 hr
Distribution: Uroepithelium of the genitourinary tract with lesser amounts found in the liver, spleen, lung, skin, periosteum, and bone marrow
Metabolism: Spleen and liver; partial depolymerization in the kidney to a large number of metabolites
Excretion: Feces (58% as unchanged drug) Urine (6% primarily as metabolites)
